Medical testing and data recording apparatus

ABSTRACT

A container includes means for testing a manifestation of health, as a urine specimen of a diabetic, and means for cumulatively recording data indicative of the results of the test.

[ Jan. 15, 1974 United States Patent [1 1 Hodges @HH wm UOZ 82 "/11 u 6/O6 24 3 at" T 1 r mlu amS my m mh u. a h a e c BCAMS 36227 34566 99999mummm 98944 2983 ,93 40289 0 259 2233 Greenville, SC. 29607 July 26,1972 Appl. No.: 275,140

[22 Filed:

Primary Examiner.loseph W. Hartary Att0rneyWilliam M. Hobby et al.

T C A R T S B A H 5 l. 50 n m ww m m 6 R3A 2 l 8/ 6 B4 3 m 3 3 6 4 3 l.l m C S. 1 U m n U 5 5 Field of"sit;;;i;1111'.11111'.111'."5467531115,143, 145,

346/17; 128/2 R, 2 W, 2 F; 206/632 R, 12; A container includes means fortesting a manifestation of health, as a urine specimen of a diabetic,and means for cumulatively recording data indicative of the results ofthe test.

1,322,515 346/33 ME X 4 Claims, 6 Drawing Figures PATENTEDJARIEIW6.766510 SHEEI30F3 J) I Q DEC.31 1 TEST OR KE- DEC.31 AM 0-40 msu.711510 AL TONE PM 0-40 msu. -1234567 90 NNNN1/4 NN 1234567690-1234567890: TT TT1/4 65 1234567 90 0 1234567690 1 1 1 1 1/2 MM1234567690 1 0000000000 00000000 000000000 .AM. 0-40 msu. PM 0-40 W50.62 1234567890"2X2X2X2X1/2 LL' 1234567690 64 1234567690 3x 3x3x3x14234567890- 1234567890 4x4 4x4 1 1234567690 MEDICAL TESTING AND DATARECORDING APPARATUS BACKGROUND OF THE INVENTION 1. Field of theInvention The present invention relates to apparatus useful in medicaltesting and recording data of such tests.

2. Description of the Prior Art Diabetes mellitus is a disease caused byan insufficient supply of insulin in the body. This lack of insulin,supplied by the pancreas, reduces the ability of the body to store orburn glucose, a form of sugar utilized by the body for the production ofenergy. As a result, the body is starved for energy, while theglucosethat could supply energy accumulates in the blood, is .collected in thekidneys, and thereafter passes into the urine. Diabetes is thus markedby excessive sugar in the urine of the diabetic.

In order to offset this disorder, diabetics daily, and.

sometimes more frequently, take injections of insulin, or alternatively,take oral compounds which act to stimulate the pancreas. The insulin isinjected subcutaneously with a hypodermic syringe and is usuallyadministered by the diabetic. With insufficient insulin, harmfulby-products (ketone bodies) are produced which act as poisons to thesystem. Further, the amount of insulin may vary from time to time,depending upon the activity and diet of the diabetic as well as otherfactors.

Thus, the sugar level in the urine of a diabetic should be testedseveral times daily to insure that the proper insulin dosage is beingadministered. Again, this testing is usually performed by the diabetic.Generally, the test simply comprises collecting a urine specimen andapplying a reagent to the specimen. The result is then compared with acolor-encoded chart, to provide a gross gauge of the percent of sugar inthe urine. Activity, food intake and ensuing insulin requirements canthen be adjusted accordingly.

The diabetic must keep a written record of these tests, in order toadjust his own insulin intake and provide his physician with informationneeded for office visits. However, many diabetics fail to maintainproper records, and rely on, memory for determining the proper insulindosage. This approach prevents the accumulation of the statistical datanecessary for proper control. Moreover, the problem is compounded whenthe information is not available to the diabetics physician forrecommendations during scheduled physicals.

Further, while studies of the variations in insulin requirements fordiabetics have been conducted under controlled conditions, there is aneed for providing means for collecting the data from daily urine sugartests for a large number of diabetics over a long period of time. Such alarge collection of data could provide useful information regarding therequired insulin dosages, and the results of insulin in terms of urinesugar and ketone poisons. Further, this information, collected on anational scale could provide a basis for further research into improvedmedicines and methods for treating diabetics. Most importantly, sincethis testing is mandatory for proper diabetic control, if the data wascollected for each individual diabetic, the diabetic himself would havea ready reference for determining the insulin requirements, dependingupon the expected diet and subsequent activity.

Several portable systems have been developed for recording data. See,for example, U. S. Pat. Nos. 3,618,836 to BUSHNELL, et al.; 3,435,192 toHART NEY; and see, US. Pat. No. 2,132,412 to GOLL- WITZER; 2,716,484 toWEPPLER; and 2,077,242 to LA PIERRE.

SUMMARY OF THE INVENTION The present invention comprises medical testingand data recording apparatus and includes a container having meanscarried thereby for testing a manifestation of health. The containerfurther carries means for cumulatively recording data indicative ofsuccessive ones of such tests.

THE DRAWING FIG. 1 is a perspective view, a portion of which is cutaway,of apparatus embodying the present invention;

FIG. 2 is a side view of the apparatus of FIG. 1;

FIG. 3 is another perspective view of the apparatus of FIG. 1; and

FIGS. 4, 5 and 6 are cut-away portions of the apparatus of FIG. 1.

DETAILED DESCRIPTION Apparatus embodying the present invention is shownand described with reference to FIGS. 1, 2 and 3. In this embodiment theapparatus comprises means for testing a urine specimen of a diabetic andmeans for cumulatively recording data from such tests.

The apparatus, referred to generally as 10, comprises a container 12. Inthe embodiment of the drawing the container 12 comprises a body havingsix faces including one face 14 having a large area opening 16 therein.The size, shape and dimensions of the container 12 are not critical.

With a specific reference to FIG. 1, the container 12 defines a cavity18 therein. The cavity is divided into an upper chamber 20 and a lowerchamber 22 by a partition 24 therebetween. The term upper and lower asused with respect to chambers 20, 22 is intended to refer to FIG. 1 fordescriptive purposes only, it being understood that the container 12 mayhave any orientation.

Another face of the container 12 opposite the one face 14 comprises alid 26 hinged about one edge. Noting FIG. 3 the inner surface of the lid26 has disposed thereon a color-encoded chart, the purpose of which willbe hereinafter described in greater detail. The lid 26 also includes adiabetic identification card 27. The lower chamber 22 is adapted toreceive some of the paraphernalia normally used by diabetics in the'daily testing of urine and in the administration of insulin. Thisincludes a test tube 28, dropper 30, a package 32 for carrying reagenttablets 34 therein, and a hypodermic syringe 36. A vial of insulin (notshown) may also be included. This paraphernalia is stored in the lowerchamber 22 when not in use, as shown in cross section in FIG. 2. NotingFIGS. 1, 2 and 3, the container 12 includes an inner wall 37 which isadapted to receive the test tube 28.

Referring again to FIG. 1, a portion of another face of the containerwhich is normal to the one face 14 comprises a removable cover 38. Whenremoved the cover 38 provides access to the upper chamber 20. The cover38 includes two apertures 40, 42 extending through the cover, theapertures each being adapted to receive a respective turning knob 41,43. The turning knobs 41, 43 each comprise a portion of respective onesof a storage reel 44 and a takeup reel 46. Each of the reels 44, 46, arerotatably mounted on a side of the upper chamber 20 opposite the cover38.

A flat tape guide 48 is juxtaposed substantially parallel to the oneface 14 and is mounted inside the upper chamber 20. A pre-encodeduniversal machine readable tape 50 is disposed around the reels 44, 46and across the tape guide 48 such that the tape 50 is exposed in theopening 16 of the one face 14. The tape 50 will be described in greaterdetail with reference to FIGS. 4, and 6. The taps guide 48 has two tabs47, 49 which are adapted to fit into two corresponding slots 51, 53 inthe cover 38.

Noting FIGS. 1 and 2, the container 12 includes a transparent protectivelayer 52, as a piece of plastic, mounted over the tape 50 in the opening16 of the one face 14. A perforating arm 54 is carried by the container12 such that the arm 54 is slidable across the one face 16 and movableinto and out of the opening 16 (note arrows in FIG. 6). A protrusion 56extends towards the container 12 from the perforating arm 54 to providemeans for perforating the tape 50. The protective layer 52 includes aslot 58 therein and the tape guide 48 has a slot 60 therein (note FIG.2) which corresponds to, and is juxtaposed opposite the slot 58 in theprotective layer. The perforating arm 54 is thus adapted to extendthrough the slot 58 in the protective layer 52 such that the protrusionperforates the tape at pre-selected areas thereon. As shown in FIG. 6, aplurality of male indentations 53 are mounted along an edge of the oneface 14, and are adapted to mate with corresponding female indentations55, such that the perforating arm 54 is properly aligned with the tape50.

Noting FIGS. 5 and 6, the tape 50 has a plurality of holes 62 along acentral portion 64 thereof. A gear 66 carried by the tape guide 48 has aplurality of gear teeth 68 adapted to sequentially engage the holes 62in the tape 50. As shown in FIG. 2, a dual-pronged spring steel member70 is mounted inside the upper chamber 20, and is adapted tofrictionally engage gear teeth 71 along the rear of each reel 44, 46,such that movement of the tape 50 along the tape guide 48 is only causedby a rotational force about one of the reels 44, 46.

The apparatus as described thus far, provides means for storing andcarrying the paraphernalia required by diabetics. In addition, theapparatus 10 comprises a portable means for testing the diabetic urinespecimen. Noting FIG. 3, the specimen is collected in the test tube 28,which is inserted in the inner wall 37. Thereafter one of the re-agenttablets 34 is inserted into the specimen,.which is thereafter comparedwith the color-encoded chart 25 to determine the sugar content of thespecimen. For example, if the urine is more close in color to the colorblock marked in the chart 25, then the diabetic is made readily awarethat there is a moderate amount of sugar in the specimen. A ketone testis similarly made. The diabetic can then adjust his insulin dosage asneeded.

An important part of the present invention is the manner in which theresults of the urine test and the insulin dosage administered by thediabetic can be cumulatively recorded for long periods of time. Anotherimportant aspect of the invention is the manner in which thisinformation can be gathered at a central data facility and processed byknown data-processing machinery.

Noting FIG. 4, these and other aspects of the invention are achieved, inpart, by employing any one of the paper tapes which are a standard inthe data-processing industry. As shown in FIG. 4, the tape ispre-encoded with a date-group and test series, each series beingrepresentative of one 24-hour period. The center portion 72 of theseries, identified by test provides means for indicating the results ofeach of four urine specimen tests at, for example, 7:00 and 1 1:00 am.and 5:00 and 10:00 pm. of a 24-hour period. As the tape 50 is rotatedaround the reels 44, 46, the tape is perforated at the appropriatepre-selected and pre-encoded area to indicate the results of the tests(note perforations in tape 50 as shown in FIG. 6).

In a similar manner the diabetic enters the insulin dosage administeredor amount of oral compound taken as a result of the corresponding urinetest. For example, the upper-left portion 74 of the date-group includesthree rows of single digit numbers I through 0. For a dosage of 64 unitsof insulin, the 6 digit in the upper row 76 is perforated and the 4digit in the center row 78 is perforated. Similarly, the tape 50 canindicate the strength of the insulin taken; for example, whether aainsyln wasAQanits( 1-4019t8 units P c.c. With respect to the oral compound,the /1, /4, etc., indicates the amount of one tablet taken. In thismanner results of the test and the insulin and oral compound dosageadministered can be cumulatively recorded.

Tape 50 can be pre-recorded with a date-group and test series for anextended period, for example, about 6 months. After all of the tape isperforated, the tape may be forwarded to a central location where thedata for a large group of diabetics may be processed.

I claim: I

1. A diabetes testing and data recording apparatus comprising:

a container;

means for collecting a urine specimen;

color-encoded means carried by said container for comparing a reagentinserted in said urine specimen with said color encoding;

a pre-encoded, machine readable tape;

means for moving said tape along one face of said container;

means for perforating said tape in pre-encoded portions to record datathereon, said data corresponding to said comparison between saidspecimen and said color encoding; and

means for sequentially taking up those portions of said tape having datarecorded thereon.

2. Apparatus as recited in claim 1 further comprising means forrecording data corresponding to a dosage of insulin administered as aresult of said comparing step.

3. Apparatus as recited in claim 2 further comprising means forrecording data corresponding to a ketone test as a result of employingsaid comparing means.

4. Apparatus as recited in claim 3 further comprising means forrecording data corresponding to a dosage of an oral compoundadministered as a result of employing said comparing means.

1. A diabetes testing and data recording apparatus comprising: acontainer; means for collecting a urine specimen; color-encoded meanscarried by said container for comparing a reagent inserted in said urinespecimen with said color encoding; a pre-encoded, machine readable tape;means for moving said tape along one face of said container; means forperforating said tape in pre-encoded portions to record data thereon,said data corresponding to said comparison between said specimen andsaid color encoding; and means for sequentially taking up those portionsof said tape having data recorded thereon.
 2. Apparatus as recited inclaim 1 further comprising means for recording data corresponding to adosage of insulin administered as a result of said comparing step. 3.Apparatus as recited in claim 2 further comprising means for recordingdata corresponding to a ketone test as a result of employing saidcomparing means.
 4. Apparatus as recited in claim 3 further comprisingmeans for recording data corresponding to a dosage of an oral compoundadministered as a result of employing said comparing means.